The Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for Recarbrio™ (imipenem, cilastatin, and relebactam; Merck), to treat adult patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP).
Recarbrio contains imipenem, a penem antibacterial, cilastatin, a renal dehydropeptidase inhibitor, and relebactam, a beta-lactamase inhibitor. It is currently approved to treat complicated urinary tract infections, including pyelonephritis, and complicated intraabdominal infections, in adult patients aged 18 years and older who have limited or no alternative treatment options.
The sNDA includes data from the phase 3 RESTORE-IMI 2 trial, which included 537 patients who required treatment with intravenous antibiotic therapy for HABP or VABP. Results showed that the trial met both the primary and secondary end points, demonstrating the statistical noninferiority of imipenem/relebactam/cilastatin compared with piperacillin/tazobactam in the modified intent-to-treat population.
Full data from the study are expected to be presented at the 30th European Congress of Clinical Microbiology & Infectious Diseases, taking place in Paris in April.
The FDA has granted the application Priority Review and assigned a Prescription Drug User Fee Act target date of June 4, 2020.
For more information visit merck.com.